Knee pain, as referenced herein, originates from several different structural or mechanical sources, for example, degenerative disease such as osteoarthritis, biomechanical dysfunction causing joint malalignment, and injury. Treatment methods vary based on the diagnosis, the severity of pain, and the training of the medical professional. Previous devices and methods to reduce knee pain include the following: (1) Prescription and over-the-counter pain medications; (2) Non-steroidal anti-inflammatory drugs (“NSAIDS”) (“anti-inflammatories”); (3) Icing; (4) Injections, which fall into two categories—steroids and high molecular weight hyaluronan (“HMWH”)-type injections; (5) Rigid knee bracing; (6) Soft bracing and taping; (7) Surgery; and (8) Physical Therapy.
Pain medications are not only expensive, but might cause side effects and may become addictive.
NSAIDS are very common in the treatment of knee pain. NSAIDS are taken orally and are generally anti-inflammatory in their effect. Disadvantages nevertheless include, among others, the long time required for them to produce any results, their wide variety in effectiveness, their great cost, and side effects caused by introducing synthetic chemicals into the body, such as, but not limited to, upset stomach, nausea, vomiting, heartburn, headache, diarrhea, constipation, drowsiness, unusual fatigue, stomach pain, swelling of the feet, and tinnitus.
Icing numbs pain and can reduce inflammation, but has limited benefits.
Injections are also designed to reduce pain. Steroids are designed to reduce inflammation and, thus, pain. Their effects last anywhere from a few weeks to a few months. HMWH injections are designed to create an artificial synovial fluid in a knee joint. This may take weeks to produce results, however, and the effectiveness varies dramatically. Injections are expensive, and also offer variable results.
Attempts to alleviate knee pain also include the application of load-bearing mechanical braces. These systems have several advantages in respect to achieving at least some degree of temporary relief. Rigid knee bracing, for example, is used to prolong the need for a total knee arthroplasty (TKA). Often called “unloaders,” these braces provide a rigid frame around the knee actually to create a lever action from opposing sides of a knee, and typically take pressure off an affected (often medial) compartment of a knee joint. There is no healing as a result of wearing such brace, just reduced pain to one degree or another. Osteoarthritic “unloader” braces for instance are cumbersome, are prone to create discomfort themselves from their compressive contact points, and are expensive.
Soft bracing has also been used, sometimes using the same mechanical principals as rigid bracing. Soft bracing has historically been some type of wrap (early on non-elastic), but with the advent of the elastic wrap (ACE® wrap), it provided something more dynamic in its response to the knee joint, which imparted a degree of comfort and effectiveness. Elastic knits were next developed in the 1950s and '1960s. More highly developed elastic knits are still being used. In the early '1970s neoprene sheet stock anywhere from about 0.32 cm to about 0.64 cm in thickness was cut into patterns and sewn or glued together so that it could be pulled over the knee and fit approximately 12.7 cm-about 17.78 cm above the knee and about 5.1 cm-about 10.16 cm below it. In the '1990s another material, called BIO SKIN®, became available, which made wearing a soft brace more comfortable but still followed a similar design in which material was worn on opposing sides of a patella.
The general idea was to cover the knee area (but not the patella) and apply compression to the knee since the pain was being generated from the knee. Thus, soft bracing for pain relief has been designed to fit onto the knee or near the patellar tendon. Any compression to the distal end of the thigh, knee, and proximal calf, was to cover the knee joint. Some braces even represent efforts to reduce the amount of material on the thigh or calf, and thereby focus on compressively surrounding only the knee joint itself. These types of soft bracing carry certain disadvantages, however. The ill-fitting nature of most designs behind the knee in the popliteal area has always been a challenge to the wearer because of discomfort.
Surgery and physical therapy likewise have, in most cases, the prolonged drawbacks of discomfort and pain.
Unfortunately, current practices in almost all cases for knee pain fall into one of these above-identified categories.
For producing increased levels of human performance there are no known methods other than performance enhancing drugs. The concept of actually increasing human performance without such drugs is unknown. The ability to increase performance instantly has been a long sought after goal for many years. E.I. du Pont de Nemours and Company, in conjunction with William Kraemer, Ph.D., conducted a five year study at Pennsylvania State University wherein they found that compression garments sustained, but did not actually increase, the immediate performance abilities of trained and untrained athletes. The Kraemer study looked at the effects of fatigue, power, and endurance with high compression and high elastic garments. Although the study found that athletes were perhaps able to maintain their ability to perform at their previously known level, data showed nothing more than a sustained level of performance. From this study and other Kraemer works, we see that swimmers now wear different apparel, and tennis players wear compression sleeves on their arms.
Hence, the prior art fails to provide an apparatus or method that adequately reduces knee pain and/or increases lower extremity performance levels.